Partnership pointers for you and your CMOs and CDMOs
Ahead of this year's Pharma Contract Manufacturing 2022 event, we spoke exclusively to Ulrich Rümenapp, Head of Launch Preparation and Coordination at Bayer AG. Here he discusses how to successfully share intellectual property (IP) with Contract Manufacturing Organisations (CMOs) and Contract Development and Manufacturing Organisations (CDMOs), top tips for overcoming complex product manufacturing challenges, and the benefits and opportunities of CMO and CDMO partnerships, to help you create and maintain positive partnerships with your CMOs and CDMOs for the development and production of your pharmaceutical products.
Successfully sharing intellectual property with CMOs and CDMOs
Firstly, you need to have certain best practices and processes in place to protect your IP, when outsourcing to a partner. There is also a lot of focus on how to capture newly generated IPs, and if there is more knowledge gained or new inventions are made, how do you manage this new IP?
It is a holistic approach, which starts with partner selection. When you select a partner, you need to consider what is needed for IP and IP protection, as this is important for creating contracts, with clauses, terms and conditions clearly stating who owns what, who gets which license and which IP belongs where. For example, you need to consider how you would run a tech transfer and what protective measures would be in place when executing the partnership. This needs to be thought through from the beginning to the end, because you need to know what would happen if you were to terminate a partnership, and what would apply for each party.
Top tips for overcoming complex product manufacturing challenges
As products, development processes, and supply networks become increasingly complex, this means that we have more in-house and external partners in the supply network. It is important to start with a good partner selection, then you need to ensure that all the contracts are in place with the right terms and conditions.
To orchestrate a complex supplier landscape, you need to have clear rules and contracts for partnerships, as well as very good project execution that includes project planning, risk management and relationship management.
The collaboration between pharmaceutical companies and CMOs and CDMOs is important, as it is the interaction between quality systems. You need to carefully look into the quality systems of the partner, as you may face scrutiny by health authorities that expect you to have a clear quality oversight about what is happening with your partner, either in development or production. Therefore, you must ensure harmonisation or alignment of quality systems. This is also true for manufacturing, supply and related activities, such as testing and release.
I think the key is good communication, good project planning and project execution, with common tools that you might use. It is also about trust, so you can openly share information, and efficiently and effectively communicate it.
Benefits and opportunities of CMO and CDMO partnerships
There are many benefits of a positive partnership between pharmaceutical companies and CMOs and CDMOs, including the ability to gain capacity and innovation, by utilising a service that you may not get somewhere else.
There is also the possibility to avoid early investments, particularly investments at risk, and build on the knowledge, capability and experience of the partner. There are variable costs with outsourcing to CMOs and CDMOs, avoiding large Capex investments, which is beneficial if you are unsure about a product or project, to help avoid risks.
Gaining greater access to new technologies is important, as building capacity can take a long time. Utilising existing technologies, platforms and facilities by partnering with the right CMOs and CDMOs, can allow you to be quicker to the market, which is a huge benefit.
Want to learn more about the benefits of partnering with CMOs and CDMOs for the development and production of your pharmaceutical products? Join Europe’s industry experts on 30 - 31 March, to discover how we can create and maintain positive partnerships with CMOs and CDMOs at the Pharma Contract Manufacturing 2022 event in Berlin.
To download the full interview click here.
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